The utilization of an intrauterine contraceptive device for birth control and the method of introducing the device into the human uterus are both well known.
In many countries, and certainly in metropolitan areas of the world, the device is placed under hospital or clinical conditions where the sterility of the IUD itself, the cleanliness of the insertion elements, and the personnel involved are predictable. Under these conditions, the risk of infection is maintained at a minimal level.
It has become apparent and increasingly important that some method of contraception be available to the emerging nations and predominantly rural societies. When dealing with this particular problem, it must be recognized that sterilization and cleanliness are, to a large extent, probabilistic values. Therefore, under field conditions in developing countries effective low cost means for maintaining the sterility of prepackaged sterile IUD's can have a beneficial consequence in reducing the number of infections arising out of routine procedures carried out on a large scale. Further, it has been noted that, the ability and/or willingness of the women to subject themselves to an inconvenience of going to a hospital or clinic in a large city often is limited.
It is important that birth control be made available to those needing or desiring it and be made as convenient as possible for women desiring such devices. It is equally as important that the health and/or lives of the women seeking birth control not be unduly endangered.
It can thus be seen that a device which will be successfully administered in a large variety of conditions must be readily available. This requires that it be packaged in such a way that it can be transported and stored at remote locations. Further, it is important that the device be packaged in a sterile condition and maintained in the sterile condition. Accommodations or devices for sterilizing the IUD itself or the tools required for a safe insertion are often not readily available or, if available, would not necessarily be correctly used. Any breach of the sterile conditions generates a danger of infection.
The utilization of sterile packaging for medical devices of many different kinds is well known in the art and is particularly illustrated by U.S. Pat. No. 3,797,493 granted to Saudek on Mar. 19, 1974. This reference discloses a single use pharmaceutical carrier wherein the seal is broken by forcibly removing a thread or the like which has an enlarged end portion. The removal of the nonwicking thread creates a small opening through which the material may be squeezed. In this device, there is no introduction of foreign material to the interior of the package since the entire process involves moving substance from the interior of the package to the exterior of the package.
U.S. Pat. No. 3,374,788 granted to Rosenthal on Mar. 26, 1968, U.S. Pat. No. 3,398,737 granted to Sheppard et al on Aug. 27, 1968, and U.S. Pat. No. 3,492,990 granted to Clarke on Feb. 3, 1970, each disclose a combination IUD and means for placement (insertion tube) and, further, each disclose a package for the devices which keeps them sterile until ready to use and in a condition for manipulation such that the IUD may be introduced into the inserter and then placed within the uterus with limited amount of contamination.
It is further to be noted that package insert/prospectus put out by manufacturers of IUDs such as Ortho Pharmaceutical of Canada Ltd. fully describe the desired handling and placement of the IUD.
With the exception of the Ortho brochure, the devices described and utilized in the prior art publications specified herein are such that if they are packaged reasonably closely to the insertion tube and the usual string secured to the IUD is passed through the tube, prior to sterilization and/or sealing, then the device could be physically compressed and pulled into the tube by simply pulling the string without requiring the clinician to touch the IUD.